Kornimate/medical-research-clean huggingface dataset:
acute effects of fitness drink formulas on energy expenditure and fat metabolism

Conditions: Caffeine; Diet, Healthy; Fat Burn; Cognitive Change; Fatigue

Summary: the purpose of this investigation was to examine the acute effects of consuming two different fitness drink formulas on the physiological response at rest and to exercise in healthy men and women.

thermogenic fitness drinks containing \~200mg of caffeine have been reported to accelerate the metabolism, increase energy, and consequently promote increased fat oxidation. however, determination of the efficacy of lower caffeine concentrations may provide additional options for individuals with preferences for reduced caffeine intake. therefore, the aim of this study was to evaluate different fitness drink formulas containing a total of 100mg and 140mg of caffeine on the physiological response at rest and to exercise. this study utilized a randomized, double-blind, placebo-controlled design. all participants completed three testing visits during which they consumed the placebo, the 100mg caffeine formula, and the 140mg caffeine formula. blood samples, blood pressure, heart rate, resting energy expenditure, substrate oxidation, and neurocognitive assessments were collected at baseline and repeated 30, 60, and 90 minutes post-ingestion. immediately following the last cognitive assessment, a maximal graded exercise test with gas analysis was conducted on a cycle ergometer to evaluate physical performance and maximal fat oxidation during exercise as well as the physiological response prior to and following exercise.

Eligibility criteria:
inclusion criteria: * young adult men and women between the ages of 18 and 35 years old. * participant is deemed by the investigator to be healthy and free of any physical limitations determined by physical activity readiness questionnaire (par-q+) and medical and activity history questionnaire (mhq). * participants will be required to be recreationally-active (defined according to american college of sports medicine standards of at least 150 minutes exercise per week and verified by information provided in the mhq). * participant is willing to abstain from dietary supplementation throughout the duration of the study as indicated in the informed consent. * participant understands the study procedures and signs forms providing informed consent to participate in the study. exclusion criteria: * inability to perform physical exercise, as determined by the par-q+. * any "yes" response in the par-q+. * history of hypertension, metabolic, hepatorenal, musculoskeletal, autoimmune or neurological disease, as determined by the mhq. * regular consumption of greater than 250 mg per day of caffeine * currently taking thyroid, antihyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications. * taking any other nutritional supplement or performance-enhancing drug (determined from mhq) that may interfere with the outcome variables of the study. * pregnancy (determined from mhq).
efficacy of a multimodal physical activity intervention in patients with chronic nonspecific low back pain

Conditions: Low Back Pain

Summary: physical activity plays an important role in the management of chronic low back pain (lbp). engaging in an active lifestyle is associated with a better prognosis. nevertheless, there is evidence to suggest that patients with chronic lbp are less likely to meet recommended physical activity levels. furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. a limitation of current exercises programs for chronic lbp is that these programs are not designed to change patient's behaviour toward an active lifestyle. therefore, the objective of this study is to investigate the short and long-term efficacy of a multimodal intervention consisting of supervised exercises, health coaching and use of an activity monitor (i.e. fitbit flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability in patients with chronic nonspecific lbp.


Eligibility criteria:
inclusion criteria: * chronic nonspecific lbp, defined as pain and discomfort localised below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration exclusion criteria: * serious spine pathology (e.g. tumors, fractures, and inflammatory diseases) * nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve) * spinal surgery * pregnancy * illiteracy * insufficient understanding of the portuguese language * cardiorespiratory diseases fibromyalgia or any other musculoskeletal condition that may affect activity and movement will be excluded

Keywords: nonspecific low back pain chronic pain
safety/efficacy of letrozole monotherapy or in combination with zoledronic acid as extended adjuvant treatment of postmenopausal patients with primary breast cancer

Conditions: Osteoporosis; Postmenopausal

Summary: this was a prospective, randomized, open-label, two arm phase iii trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. patients were treated with letrozole 2.5 mg orally per day or letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an infusion. this trial did not recruit patients in the united states.


Eligibility criteria:
inclusion criteria: * compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months) * performance status 0-2 (eastern cooperative oncology group) * patients without severe osteoporosis at study entry * no evidence of relapse at the time of randomization * adequate function of bone marrow, kidney, and liver exclusion criteria: * estrogen- and progesterone-receptor status negative or unknown * completion of adjuvant tamoxifen therapy more than 6 months prior to study start * inflammatory breast cancer * current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures. * recent (within 6 weeks) or planned dental or jaw surgery * history of diseases with influence on bone metabolism such as paget's disease and primary overactive parathyroid * prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate) * patients with previous or concomitant cancers (not breast cancer) within the past 5 years except adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. patients with previous other cancer(s) must have been disease-free for at least 5 years. * patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start. additional protocol defined inclusion/exclusion criteria may apply.

Keywords: breast cancer postmenopausal bone mineral density zoledronic acid letrozole extended adjuvant treatment. postmenopausal women with primary hormone receptor positive breast cancer
safety and efficacy in pediatric ms patients prescribed tysabri

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (ms) population.

all available retrospective and prospective data from pediatric ms participants who have received at least 1 dose of natalizumab before turning 18 years old and before 31mar2015 will be used in this study. prospective data are defined as data to be collected in the future, i.e., from new participants not included in the first data transfer or additional data from existing participants that were not included in the first data transfer. existing biospecimen samples will be evaluated but not collected as part of this study.

Eligibility criteria:
key inclusion criteria: * all available retrospective and prospective data from pediatric ms patients who have received at least 1 dose of natalizumab before turning 18 years old and before 31 march 2015. * in addition, patients must be registered in touch (us patients only), enrolled in a biogen sponsored postmarketing observational study (e.g., top (nct00493298) or tygris (nct00477113,nct00483847)), or in a country-specific tysabri registry. * adequate data received by biogen by 30 september 2015 will be used for this meta-analysis including data collected after a patient may have turned 18 years old. key exclusion criteria: * data received by biogen after 30 september 2015 will not be included in the statistical analyses note: other protocol-defined inclusion/exclusion criteria may apply

Keywords: pediatric
the search for viral and bacterial etiology of varicocele

Conditions: Varicocele; Viral Infection; Bacterial Infections; Sonic Hedgehog Expression; VEGF Expression

Summary: this study is to answer the question is there any relationship between viral ( hsv 1 , hsv 2 , hpv 6/11, cmv, hhv 6 , hhv 8, bkv) or bacterial (porphyromonas gingivalis, treponema denticola, tannerella forsythia, fusobacterium nucleatum) infection and occurrence of varicocele in men.


Eligibility criteria:
inclusion criteria: * in experimental arm - varicocele grade ii or iii and infertility and/or pain exclusion criteria: * in control arm: presence of varicocele in ultrasound before surgery
pancreatic metal stents in chronic pancreatitis

Conditions: Refractory Pancreatic Duct Strictures; Painful Chronic Pancreatitis

Summary: the purpose of this study is to document the performance of a new fully covered self expanding metal stents (fcsems) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis.

this study is a prospective, single arm, pre-approval study. treatment of 10 patients will take place at 1-3 clinical centers in two phases. phase 1 will include treatment of five patients with a three month stent indwell period at one clinical center. phase 2 will include treatment of five additional patients with a 3-6 month stent indwell period at 1-3 clinical centers. expected duration of participation for each patient is approximately 27 months for phase 1 and approximately 27-30 months for phase 2. all patients, regardless of phase, will be followed for 24 months after stent removal. post-removal follow-up visits will occur at 1, 3, 6, 12, 18 and 24 months.

Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study 3. chronic pancreatitis of cremer type iv (segmental pancreatitis of the head of the pancreas). see appendix for cremer classifications. 4. improvement of pancreatic pain during previous placement of a single pancreatic plastic stent 5. at least one of the following: * abdominal pain most probably related to chronic pancreatitis * recurrent dominant main pancreatic duct stricture in the head of the pancreas after prior indwell of pancreatic plastic stent(s) if pain score was available prior to preceding stent therapy. recurrent stricture to be visually assessed at endoscopy and confirmed by recurrent main pancreatic duct dilatation at mrcp. * relapsing pain due to pancreatic duct stent blockage (with only one stent in place) 6. prior endoscopic pancreatic sphincterotomy (eps), historically or to be provided at time of sems placement with informed patient consent. exclusion criteria: 1. strictures caused by malignancies 2. biliary strictures caused by chronic pancreatitis 3. perforated duct. 4. ansa pancreatica or h anatomy 5. pancreatic duct stenoses not located in the head of the pancreas 6. failed access during an attempted ercp on a prior date 7. prior pancreatic metal stent(s) 8. concurrent eswl (extracorporeal shock wave lithotripsy) during the same treatment session 9. patients for whom endoscopic techniques are contraindicated. 10. patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor 11. inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational center that
a clinical investigation of the taperloc® microplasty™ hip system

Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis

Summary: the purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the taperloc® microplasty™ hip system.


Eligibility criteria:
inclusion criteria: * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * rheumatoid arthritis. * correction of functional deformity. * treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. * revision of previously failed femoral head resurfacing component exclusion criteria: absolute contraindications include: * infection, * sepsis, and * osteomyelitis. relative contraindications include: * uncooperative patient or patient with neurologic disorders who are incapable of following directions, * osteoporosis, * metabolic disorders which may impair bone formation, * osteomalacia, * distant foci of infections which may spread to the implant site, * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, * vascular insufficiency, muscular atrophy, or neuromuscular disease.

Keywords: total hip replacement total hip arthroplasty minimally invasive microplasty hip arthritis
efficacy/ safety of omalizumab in patients with seasonal allergic asthma and seasonal allergic rhinoconjunctivitis

Conditions: Allergic Asthma

Summary: efficacy/ safety for the combination of anti-ige (omalizumab) and specific immunotherapy (depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.

this was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-ige (omalizumab) and specific immunotherapy (depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. during the open-label period, all patients received depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. the extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with depigoid in seasonal asthma. this study was a follow-up to the core ige025ade03 study, in which patients received omalizumab treatment. in this follow-up study, no patient received omalizumab.

Eligibility criteria:
inclusion criteria: * males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum ige level ≥ 30 to ≤ 700 iu/ml (suitable weight for dosing) * patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pollen) and allergic asthma with concomitant seasonal allergic rhinoconjunctivitis within \> 2 previous seasons * patients with a positive rast (\>cap2) result for grass pollen (and/or rye pollen) specific ige at screening (visit 1 (v1) or within the previous 12 months. * patients with fev1 \> 80% of the predicted normal value for the patient at screening \[v1\](demostrable at least 6 hours after last short acting b-2 agonist use or 12 hours after last long b-2 acting agonist use). exclusion criteria: * females of childbearing potential: pregnancy, birth control,breast-feeding * concurrent diseases/conditions and history of other diseases/conditions 1. patients who have a positive history of significant clinical manifestations of allergy as a result of sensitization against tree pollen allergens, weed allergens and perennial allergens (e.g. aspergillus spores, animal dander, house dust mite). 2. patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s). * ingredient hypersensitivity 1. patients with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication, any immunotherapy, or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin). 2. patients with hypersensitivity to the trail's asthma rescue- or escalation-medication or related drugs.
foot care assessment and relation to diabetic complications

Conditions: Diabetic Foot

Summary: screening for diabetic foot in patients attending at diabetic center at assiut university and its relations to diabetic microvascular complications (nephropathy, neuropathy and retinopathy) and macrovascular complications (stroke , myocardial infarction and peripheral arterial diseases). footwear assessment in diabetic patient. evaluation of integrated foot care program in moderate and high-risk patients for diabetic foot. evaluation of knowledge and practice of diabetic foot

the international diabetes federation (idf) has identified egypt as the ninth leading country in the world for the number of patients with t2d. the prevalence of t2d in egypt was almost tripled over the last 2 decades. this sharp rise could be attributed to either an increased pattern of the traditional risk factors for t2d such as obesity and physical inactivity and change in eating pattern or other risk factors unique to egypt . diabetic foot complications are the most common cause of non-traumatic lower extremity amputations in the industrialized world, may cause death or physical and psychical disability, has a great impact on quality of life, and represents a high cost for society ( . the term diabetic foot encompasses any lesion in the feet: infection, ulcer, and destruction of deep tissues occurring as the result of diabetes and its complications . the absence of symptoms in a person with diabetes does not exclude foot disease; they may have asymptomatic neuropathy, peripheral artery disease, pre-ulcerative signs, or even an ulcer. every diabetic patient will be subjected to 1. medical history. 2. therapeutic history: antidiabetic drugs (type, duration), other medications for obesity, hypertension and dyslipidemia 3. complete physical examination. 4. the following work up; * knowledge questionnaire developed by hasnain and colleagues and the nottingham assessment of functional foot care (naffc) . * screening for diabetic foot . * fundus examination * ecg * the following investigations: alb/cre ration, hba1c, lipid profile, blood urea, serum creatinine * abdominal ultrasound * ankle brachial index (abi) 5. integrated foot care program will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months vs conventional education

Eligibility criteria:
inclusion criteria: adult patient with diabetic mellitus exclusion criteria: major amputation of lower limbs. end stage organ failure. diabetic patient less than 18 years or more than 75. pregnant diabetic women. connective tissue disease
safety, tolerability, pk, and pd study of pgn-edodm1 in participants with myotonic dystrophy type 1

Conditions: Myotonic Dystrophy 1

Summary: the primary purpose of the study is to evaluate the safety and tolerability of single intravenous (iv) doses of pgn-edodm1 administered to participants with myotonic dystrophy type 1 (dm1). the study consists of 2 periods: a screening period (up to 30 days) and a treatment and observation period (16 weeks).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of dm1, as defined as having a repeat sequence in the dmpk gene with at least 100 ctg repeats * medical research council (mrc) score of ≥ grade 4- in bilateral tibialis anterior (ta) muscles (the ability to move through full range of motion and hold against at least moderate pressure from the examiner) * presence of myotonia exclusion criteria: * congenital dm1 * known history or presence of any clinically significant conditions that may interfere with study safety assessments * abnormal laboratory tests at screening * medications specific for the treatment of myotonia within 2 weeks prior to screening * percent predicted forced vital capacity (fvc) \<40% note: other inclusion and exclusion criteria may apply.

Keywords: myotonic dystrophy muscular dystrophies genetic diseases, inborn neuromuscular diseases nervous system diseases musculoskeletal diseases myotonic disorders muscular disorders, atrophic heredodegenerative disorders, nervous system neurodegenerative diseases muscular diseases steinert disease
long-term safety and efficacy study of milnacipran in pediatric patients with primary fibromyalgia

Conditions: Primary Fibromyalgia

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.


Eligibility criteria:
inclusion criteria: * patients must have completed or discontinued prematurely from lead-in study, mln-md-14, tolerating a minimum daily dose of 50mg milnacipran exclusion criteria: * can not tolerate a minimum daily dose of 50mg milnacipran * significant risk of suicidality * pregnant or breastfeeding

Keywords: fibromyalgia pediatric fibromyalgia adolescent fibromyalgia milnacipran savella loss of therapeutic response forest research institute pain fatigue serotonin norepinephrine reuptake inhibitors
montelukast in bronchiolitis obliterans syndrome

Conditions: Bronchiolitis Obliterans; Lung Transplantation; Graft Rejection

Summary: chronic rejection (or bronchiolitis obliterans syndrome-bos) is a major cause of mortality and morbidity after lung transplantation. because montelukast has been shown to be of some efficacy in a similar disease (obliterative bronchiolitis after bone marrow transplantation), the investigators would like to test if montelukast can indeed slow down the progression of chronic rejection after lung transplantation.

* prospective, interventional, randomized, double-blind, placebo-controlled trial. * clinical setting (tertiary university hospital). * investigator-driven, no pharmaceutical sponsor. * lung transplant recipients. * add-on of study-drug (placebo or montelukast) to 'standard of care' * 1:1 inclusion ratio (placebo:montelukast). * randomisation at diagnosis of chronic rejection after informed consent.

Eligibility criteria:
inclusion criteria: * diagnosis of fbos * signed informed consent * age at least 18 years old at moment of transplantation * able to take oral medication exclusion criteria: * retransplantation * previous organ transplantation * multi organ transplantation

Keywords: montelukast cysteinyl leukotriene lung transplantation bronchiolitis obliterans syndrome